Refractive ErrorsNCT07891884
Consistency of an Automated Subjective Refraction Program Between Personnel With Diverse Professional Backgrounds and Senior Optometrists
A study testing Nurse-Operated Automated Subjective Refraction, Village Doctor-Operated Automated Subjective Refraction and Lay Personnel-Operated Automated Subjective Refraction in people with Refractive Errors, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
Trial summary
This study aims to evaluate the performance of automated subjective refraction performed by operators with different professional backgrounds. By comparing their results with those obtained by a senior optometrist using the same automated refraction program, the study will assess agreement in refractive prescriptions… Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors
- What is being tested?
- Nurse-Operated Automated Subjective Refraction, Village Doctor-Operated Automated Subjective Refraction and Lay Personnel-Operated Automated Subjective Refraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 7 years or older, of either sex. ② Astigmatism magnitude of 1.50 D or less. ③ Voluntary participation in the study with written informed consent.
Who cannot join
- Concomitant ocular diseases causing opacity of the ocular media, such as cataract, glaucoma, or fundus disease.
- History of ocular trauma or intraocular surgery.
- Manifest strabismus or significant binocular vision dysfunction. ④ Inability to follow and respond to system instructions. ⑤ Only one eye meeting the eligibility criteria.
- Considered unsuitable for participation by the investigator.
About this study
This study aims to evaluate the performance of automated subjective refraction performed by operators with different professional backgrounds. By comparing their results with those obtained by a senior optometrist using the same automated refraction program, the study will assess agreement in refractive prescriptions and examine examination efficiency, participant experience, and safety, thereby providing evidence for the further application of automated subjective refraction technology.
- Conditions
- Refractive Errors
- Being tested
- Nurse-Operated Automated Subjective Refraction, Village Doctor-Operated Automated Subjective Refraction, Lay Personnel-Operated Automated Subjective Refraction, Senior Optometrist-Operated Automated Subjective Refraction
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Operated Automated Subjective RefractionDiagnostic test
A trained nurse operates the automated refraction program to complete the full subjective refraction procedure and obtain spherical power, cylindrical power, and cylinder axis.
Village Doctor-Operated Automated Subjective RefractionDiagnostic test
A trained village doctor operates the automated refraction program to complete the full subjective refraction procedure and obtain spherical power, cylindrical power, and cylinder axis.
Lay Personnel-Operated Automated Subjective RefractionDiagnostic test
Trained lay personnel who have passed competency assessment operate the automated refraction program to complete the full subjective refraction procedure and obtain spherical power, cylindrical power, and cylinder axis.
Senior Optometrist-Operated Automated Subjective RefractionDiagnostic test
A senior optometrist operates the same automated refraction program according to a standardized procedure to obtain spherical power, cylindrical power, and cylinder axis. These measurements serve as the reference results for comparison.
| Study group | Role | What they receive |
|---|---|---|
| Nurse First | Experimental | Participants first undergo automated subjective refraction performed by a trained nurse, followed by a rest interval of at least 20 minutes and then automated subjective refraction performed by a senior optometrist using the same program. The two operators are blinded to each other's refraction results. Receives: Diagnostic Test: Nurse-Operated Automated Subjective Refraction; Diagnostic Test: Senior Optometrist-Operated Automated Subjective Refraction |
| Senior Optometrist First: Nurse Group | Experimental | Participants first undergo automated subjective refraction performed by a senior optometrist, followed by a rest interval of at least 20 minutes and then automated subjective refraction performed by a trained nurse using the same program. The two operators are blinded to each other's refraction results. Receives: Diagnostic Test: Nurse-Operated Automated Subjective Refraction; Diagnostic Test: Senior Optometrist-Operated Automated Subjective Refraction |
| Village Doctor First | Experimental | Participants first undergo automated subjective refraction performed by a trained village doctor, followed by a rest interval of at least 20 minutes and then automated subjective refraction performed by a senior optometrist using the same program. The two operators are blinded to each other's refraction results. Receives: Diagnostic Test: Village Doctor-Operated Automated Subjective Refraction; Diagnostic Test: Senior Optometrist-Operated Automated Subjective Refraction |
| Senior Optometrist First: Village Doctor Group | Experimental | Participants first undergo automated subjective refraction performed by a senior optometrist, followed by a rest interval of at least 20 minutes and then automated subjective refraction performed by a trained village doctor using the same program. The two operators are blinded to each other's refraction results. Receives: Diagnostic Test: Village Doctor-Operated Automated Subjective Refraction; Diagnostic Test: Senior Optometrist-Operated Automated Subjective Refraction |
| Trained Lay Personnel First | Experimental | Participants first undergo automated subjective refraction performed by trained lay personnel, followed by a rest interval of at least 20 minutes and then automated subjective refraction performed by a senior optometrist using the same program. The two operators are blinded to each other's refraction results. Receives: Diagnostic Test: Lay Personnel-Operated Automated Subjective Refraction; Diagnostic Test: Senior Optometrist-Operated Automated Subjective Refraction |
| Senior Optometrist First: Trained Lay Personnel Group | Experimental | Participants first undergo automated subjective refraction performed by a senior optometrist, followed by a rest interval of at least 20 minutes and then automated subjective refraction performed by trained lay personnel using the same program. The two operators are blinded to each other's refraction results. Receives: Diagnostic Test: Lay Personnel-Operated Automated Subjective Refraction; Diagnostic Test: Senior Optometrist-Operated Automated Subjective Refraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement in refractive prescriptions between operators from different professional backgrounds and senior optometrists using the same automated refraction program
Measured: Day 1, after completion of both subjective refraction examinations
Secondary outcomes (3)
Examination time for comparison operators and senior optometrists using the automated refraction program
Measured: Day 1, during each subjective refraction examination.
Participant acceptance, comfort, and satisfaction with the automated refraction procedure
The questionnaire assesses three aspects: understanding and operation, comfort and visual fatigue, and acceptance and willingness to use. Each item is rated on a 5-point Likert scale from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating a more favorable evaluation.
Measured: Day 1, after completion of both subjective refraction examinations.
Adverse events and ocular discomfort during the examinations
Measured: Day 1, during both subjective refraction examinations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891884
- Sponsor's protocol ID
- 2026KYPJ108
- Status last verified
- Sep 2026
- First submitted
- 11 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No external sharing of individual participant data is currently planned.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consistency of an Automated Subjective Refraction Program Between Personnel With Diverse Professional Backgrounds and Senior Optometrists
- ClinicalTrials.gov ID
- NCT07891884
- Acronym / sponsor ID
- 2026KYPJ108
- Conditions
- Refractive Errors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the performance of automated subjective refraction performed by operators with different professional backgrounds. By comparing their results with those obtained by a senior optometrist using the same automated refraction program, the study will assess agreement in refractive prescriptions and examine examination efficiency, participant experience, and safety, thereby providing evidence for the further application of automated subjective refraction technology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Nurse First | Experimental | Diagnostic Test: Nurse-Operated Automated Subjective Refraction, Diagnostic Test: Senior Optometrist-Operated Automated Subjective RefractionParticipants first undergo automated subjective refraction performed by a trained nurse, followed by a rest interval of at least 20 minutes and then automated subjective refraction performed by a senior optometrist using the same program. The two operators are blinded to each other's refraction results. |
| Senior Optometrist First: Nurse Group | Experimental | Diagnostic Test: Nurse-Operated Automated Subjective Refraction, Diagnostic Test: Senior Optometrist-Operated Automated Subjective RefractionParticipants first undergo automated subjective refraction performed by a senior optometrist, followed by a rest interval of at least 20 minutes and then automated subjective refraction performed by a trained nurse using the same program. The two operators are blinded to each other's refraction results. |
| Village Doctor First | Experimental | Diagnostic Test: Village Doctor-Operated Automated Subjective Refraction, Diagnostic Test: Senior Optometrist-Operated Automated Subjective RefractionParticipants first undergo automated subjective refraction performed by a trained village doctor, followed by a rest interval of at least 20 minutes and then automated subjective refraction performed by a senior optometrist using the same program. The two operators are blinded to each other's refraction results. |
| Senior Optometrist First: Village Doctor Group | Experimental | Diagnostic Test: Village Doctor-Operated Automated Subjective Refraction, Diagnostic Test: Senior Optometrist-Operated Automated Subjective RefractionParticipants first undergo automated subjective refraction performed by a senior optometrist, followed by a rest interval of at least 20 minutes and then automated subjective refraction performed by a trained village doctor using the same program. The two operators are blinded to each other's refraction results. |
| Trained Lay Personnel First | Experimental | Diagnostic Test: Lay Personnel-Operated Automated Subjective Refraction, Diagnostic Test: Senior Optometrist-Operated Automated Subjective RefractionParticipants first undergo automated subjective refraction performed by trained lay personnel, followed by a rest interval of at least 20 minutes and then automated subjective refraction performed by a senior optometrist using the same program. The two operators are blinded to each other's refraction results. |
| Senior Optometrist First: Trained Lay Personnel Group | Experimental | Diagnostic Test: Lay Personnel-Operated Automated Subjective Refraction, Diagnostic Test: Senior Optometrist-Operated Automated Subjective RefractionParticipants first undergo automated subjective refraction performed by a senior optometrist, followed by a rest interval of at least 20 minutes and then automated subjective refraction performed by trained lay personnel using the same program. The two operators are blinded to each other's refraction results. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Age 7 years or older, of either sex. ② Astigmatism magnitude of 1.50 D or less. ③ Voluntary participation in the study with written informed consent.
Key exclusion criteria (4 listed)
- Concomitant ocular diseases causing opacity of the ocular media, such as cataract, glaucoma, or fundus disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-Operated Automated Subjective RefractionA trained nurse operates the automated refraction program to complete the full subjective refraction procedure and obtain spherical power, cylindrical power, and cylinder axis. | Diagnostic test | Nurse First, Senior Optometrist First: Nurse Group |
| Village Doctor-Operated Automated Subjective RefractionA trained village doctor operates the automated refraction program to complete the full subjective refraction procedure and obtain spherical power, cylindrical power, and cylinder axis. | Diagnostic test | Senior Optometrist First: Village Doctor Group, Village Doctor First |
| Lay Personnel-Operated Automated Subjective RefractionTrained lay personnel who have passed competency assessment operate the automated refraction program to complete the full subjective refraction procedure and obtain spherical power, cylindrical power, and cylinder axis. | Diagnostic test | Senior Optometrist First: Trained Lay Personnel Group, Trained Lay Personnel First |
| Senior Optometrist-Operated Automated Subjective RefractionA senior optometrist operates the same automated refraction program according to a standardized procedure to obtain spherical power, cylindrical power, and cylinder axis. These measurements serve as the reference results for comparison. | Diagnostic test | Nurse First, Senior Optometrist First: Nurse Group, Senior Optometrist First: Trained Lay Personnel Group, Senior Optometrist First: Village Doctor Group, Trained Lay Personnel First, Village Doctor First |
Primary outcome
Agreement in refractive prescriptions between operators from different professional backgrounds and senior optometrists using the same automated refraction program
Time frame: Day 1, after completion of both subjective refraction examinations
3 secondary outcomes
Examination time for comparison operators and senior optometrists using the automated refraction program
Time frame: Day 1, during each subjective refraction examination.
Participant acceptance, comfort, and satisfaction with the automated refraction procedure
Time frame: Day 1, after completion of both subjective refraction examinations.
Adverse events and ocular discomfort during the examinations
Time frame: Day 1, during both subjective refraction examinations.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No. No external sharing of individual participant data is currently planned.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Operated Automated Subjective Refraction, Village Doctor-Operated Automated Subjective Refraction and Lay Personnel-Operated Automated Subjective Refraction in people with Refractive Errors, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement in refractive prescriptions between operators from different professional backgrounds and senior optometrists using the same automated refraction program (time frame: Day 1, after completion of both subjective refraction examinations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.